TRANSLATIONAL ASPECTS OF SECONDARY PHARMACOLOGY

Laszlo Urban

Preclinical Secondary Pharmacology, Novartis Institute for Biomedical Research, Cambridge, MA, USA

Abstract

Recently, the pharmaceutical industry has introduced broader and earlier safety risk assessment for better understanding of molecular bases of toxic reactions which are often shared between different drugs. Pharmaceutical product development requires parallel, integrated optimization of efficacy and safety. Predictive in vitro and in silico tools have been developed for early risk assessment which enable the inexpensive de-prioritization of chemical structures associated with ADRs, and prevents compounds with “toxic” off-target effects entering clinical trials. The introduction of these tools can result in diminished attrition, better side effect profiles, improved compliance and significant savings for drugs. In this presentation, we will review the strategy of early safety risk assessment/mitigation of drug candidates based on identification of molecular targets, pathways associated with pathophysiological clinical consequences.